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Encore Medical, LP FDA Recalls
47 recalls on file across devices, 0 of them Class I and 45 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product DescrClass IIFeb 16, 2026Due to packaging discrepancy with incorrect product size mix |
| Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product DescrClass IIFeb 16, 2026Due to packaging discrepancy with incorrect product size mix |
| Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/CClass IIJan 15, 2026Knee and Humeral socket implants contain incorrect labeling. |
| Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus MoClass IIJan 15, 2026Knee and Humeral socket implants contain incorrect labeling. |
| Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707Class IIJan 15, 2026Knee and Humeral socket implants contain incorrect labeling. |
| EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: Class IIJan 5, 2026942-01-40G acetabular system package was found to contain 94 |
| EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705Class IIJan 5, 2026942-01-40G acetabular system package was found to contain 94 |
| Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 PrClass IIJul 18, 2025Their is a potential that the reamer may kick or bind up d |
| Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8Class IIJul 18, 2025Their is a potential that the reamer may kick or bind up d |
| Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Class IIJul 18, 2025Their is a potential that the reamer may kick or bind up d |
| Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software VersionClass IIJul 18, 2025Their is a potential that the reamer may kick or bind up d |
| Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34Class IIJul 9, 2025Knee implants contain incorrect labeling (size and/or side i |
| Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 34Class IIJul 9, 2025Knee implants contain incorrect labeling (size and/or side i |
| Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/CatalClass IIJun 12, 2025Due to packaging discrepancy with the incorrect tibial inser |
| Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/CatalClass IIJun 12, 2025Due to packaging discrepancy with the incorrect tibial inser |
| Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog NumbeClass IIJun 2, 2025Due to packaging discrepancy with the incorrect tibial inser |
| Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog NumbeClass IIJun 2, 2025Due to packaging discrepancy with the incorrect tibial inser |
| Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-1Class IIMay 28, 2025Package labeling for Altivate Reverse Torx Peripheral screw |
| Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-1Class IIMay 28, 2025Package labeling for Altivate Reverse Torx Peripheral screw |
| Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-1Class IIMay 28, 2025Package labeling for Altivate Reverse Torx Peripheral screw |
| Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-1Class IIMay 28, 2025Package labeling for Altivate Reverse Torx Peripheral screw |
| EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703Class IIDec 18, 20245R 16MM knee tibial insert package may contain knee tibial i |
| EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706Class IIDec 10, 2024Knee insert package may contain an acetabular system, which |
| DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO Class IINov 10, 2023Due to incorrect product/device within packaging. |
| REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2Class IIOct 5, 2023Mislabeling |
| Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797Class IIOct 5, 2023Mislabeling |
| DJO EMPOWR Knee Punch Handle, REF: 801-05-040Class IISep 29, 2023Knee punch handle tip is breaking during surgery due to the |
| RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant comClass IISep 25, 2023Two different humeral socket Insert devices were swapped dur |
| RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.Class IISep 25, 2023Two different humeral socket Insert devices were swapped dur |
| RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.Class IISep 6, 2023Coating hex did not engage with the Straight Mod Hexdriver o |
| REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130Class IIAug 22, 2023Reverse shoulder prosthesis package that should contain 5mmx |
| EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40HClass IIAug 22, 2023Knee insert and acetabular system parts were swapped within |
| EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705Class IIAug 22, 2023Knee insert and acetabular system parts were swapped within |
| DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106Class IIAug 4, 2023Orthopedic device components were not subjected to final ste |
| DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108Class IIAug 4, 2023Orthopedic device components were not subjected to final ste |
| DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030Class IIAug 4, 2023Orthopedic device components were not subjected to final ste |
| DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443Class IIAug 4, 2023Orthopedic device components were not subjected to final ste |
| DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-CoaClass IIAug 4, 2023Orthopedic device components were not subjected to final ste |
| EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108Class IIFeb 28, 2023Patella drills are marked with incorrect diameter size of 5. |
| EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-7Class IIDec 22, 2022Tibial insert implant large boxes were labeled small and the |
| EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.Class IIAug 12, 2022Hip liner implant boxes may contain knee inserts and knee in |
| EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.Class IIAug 12, 2022Hip liner implant boxes may contain knee inserts and knee in |
| DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708Class IIMay 5, 2022A right, size 8, knee tibial insert package may include a mi |
| AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000,Class IIJun 28, 2021Complaints have been received concerning the humeral stem fa |
| DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00Class IIMay 12, 2021Packaging mixup; There is a potential that packaging identif |
| DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00Class IIMay 12, 2021Packaging mixup; There is a potential that packaging identif |
| DJO EMPOWR KNEE Femoral SizerClass IIFeb 5, 2021Incorrect assembly of a subcomponent by a vendor and as a re |